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Retrospective medical record research: Reflections of a unsponsored researcher.

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Bature, Fidelia; Vseteckova, Jitka; Pang, Dong; Pappas, Yannis and Guinn, Barbara (2019). Retrospective medical record research: Reflections of a unsponsored researcher. BJSTR Biomed J Sci & Tech Res, 21(4) pp. 16080–16086.

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ISSN: 2574 -1241 DOI: 10.26717/BJSTR.2019.21.003642

Retrospective Medical Record Research: Reflections of A Unsponsored Researcher

Fidelia Bature1,4*, Jitka Vsectekova2, Dong Pang3, Yannis Pappas3 and Barbara Guinn4 1Faculty of Health and Social Studies, School of Applied Social Studies, University of , UK 2Faculty of Wellbeing, Education & Language Studies, School of Health, Wellbeing and Social Care, UK 3Institute for Health Research, Bury Campus, University of Bedfordshire, UK 4Department of Biomedical Sciences, Faculty of Health Sciences, University of Hull, UK *Corresponding author: Fidelia Bature, Faculty of Health and Social Studies, School of Applied Social Studies, University of Bedfordshire, , LU1 3JU, UK

ARTICLE INFO Abstract

Received: September 24, 2019 Published: October 01, 2019 of a doctoral thesis involving the analysis of primary care data. The aim of the study was to identifyThis article patterns is a reflective in signs and narrative symptoms by the preceding author following a clinical the diagnosis successful of Alzheimer’s completion Disease (AD). Here, we discuss the challenges of conducting research using the patient Citation: Fidelia B, Jitka V, Dong P, medical health records as a non-sponsored researcher. The narrative explores the Yannis P, Barbara G. Retrospective experiences of undertaking practice recruitment, issues that arose around access to data and the requirement for stakeholder commitment, with proposals for other similar of A Unsponsored Researcher. Biomed JMedical Sci & Tech Record Res Research: 21(4)-2019. Reflections BJSTR. cycle was adopted in this narrative. This model encourages a clear description of events, MS.ID.003642. analysisprojects ofthat personal attempt feelings, to undertake evaluation research of the using experience, patients’ conclusions data. The as Gibbs to the reflective options that were considered and actions to take if faced with the same study methods (involving Abbreviations: AD: Alzheimer’s primary care practitioners and/or the review of patient records). It also allows a Disease; CCG: Clinical Commissioning Group; CPRD: Clinical Practice Research undertaking a retrospective medical record research. The researcher also proposes Database; CRN: Clinical Research somestructured recommendation(s) reflection while to simultaneouslyovercoming barriers discussing to recruitment the barriers in primary and facilitators care. to Network; GP: general practitioner; MK: Milton Keynes; NIHR: National Institute Keywords: Retrospective Medical Record Review; Unsponsored Researcher; General for Health Research; REC: Research Ethics Committee; RMRR: Retrospective Aims medical record review; STEM: Science, Practice; Interview; Reflection Technology, Engineer and Mathematics care To review the difficulties faced when accessing patient medical records from primary

by a non-sponsored researcher To recommend best practice that can help circumvent some of the difficulties faced

Introduction symptoms preceding the clinical diagnosis of Alzheimer’s Disease Retrospective Medical Record Review (RMRR), that collates (AD), using a RMRR. General Practitioners (GPs) interpretation of patients’ personal AD is a condition that affects the cognitive and functional faced by an international student while undertaking a doctoral abilities of individuals. The disease is associated with stigmatisation experiences, can be challenging. This article presents the difficulties research project that was designed to encompass multiple GP [1,2] due to a lack of insight by patients and understanding by their practices and partners to ensure broad applicability. During this carers, the anticipation of the course of the disease, and general time, research was undertaken to identify patterns in the signs and public perceptions of AD [1,3]. The fear of a loss of independence

Copyright@ Fidelia Bature | Biomed J Sci & Tech Res | BJSTR. MS.ID.003642. 16080 Volume 21- Issue 4 DOI: 10.26717/BJSTR.2019.21.003642 and particularly of becoming redundant can affect patients’ by the practices included limited human resources, managerial and psychologically and appears to be the main reason that the reporting of memory loss does not happen in a timely manner [1]. incentives that the researcher could offer to practices. gatekeeper issues, as well as the lack of financial compensation/ While all research presents consequences of some kind, RMRR Recruitment of practices could be challenging and slowed down is increasingly being used to identify issues regarding health and the progress of research to the extent that it could ultimately lead to disease [4] but is sensitive in nature. This is because it comes the termination of the study; however, in this research, it did slow down the progress and extended the time of completion. The issues regarding ethics and stigma, as presented in most diseases but faced could be overcome by extending the original proposed time; with (potential) ramifications especially when dealing with issues especially those involving cognitive decline such as AD [1]. Medical records present the opportunity to undertake studies without the cost of the research, each of which could present an enormous reducing the power of generalization and the inflation of the overall time-consuming process of recruiting individuals for longitudinal challenge to a unsponsored researcher [8] and could have ethical

for refusal. It has been estimated that less than one-third of primary studies; it can reduce the financial burden of a real-time study. implications in and of itself especially when there is no justification taking and present ethics committees with concerns around the care studies successfully recruit health care practices within the However, they are limited in their content, influenced by GP record invasion of privacy, the security of information and the integrity of originally proposed time-frame in the UK [9]; the success becomes the representation of patients’ data [5,6]. less with an unsponsored researcher as indicated in this research. Even when the research team is made of a number of researchers, There is a risk that the review of medical records could identify other potentially sensitive health conditions [7] and patients are ideas being translated to solutions, while the need to base actions often not consented in anticipation of a researchers’ review of there is difficulty in practice recruitment [10], which may hinder on researched evidence continues. their medical records. The RMRR study was undertaken to meet the requirement of a longitudinal study in this research while Being a self-funded PhD student, and in some senses a lone recognizing the challenges associated with it. Several ethical and researcher, comes with its rewards. It is a time of great interest and methodological issues were observed during this study including unhindered by considerations of a team of data collectors. There is sober reflection and offers the opportunity to climb to great heights often comes via practice managers who often act as primary care also the tendency for long and detailed investigations in order to the difficulties of recruiting GPs because accessibility to them gatekeepers. Other challenges included time constraints on GPs, a be precise and not to miss any opportunity, made much harder by lack of resources and on occasion, a lack of cooperation by practice working alone because of the time taken to collect the same amount of data. The isolation can make it easier for the lone researcher to quit the game entirely, especially where slow progress prevents the managers that appeared to conflict with the GPs own willingness These factors impact negatively on all research. Despite unlimited collection of enough data for analysis within time constraints. The to participate. There were also issues of financial incentives. enthusiasm by the researcher and a willingness to continue to early part of the PhD researchers’ career is also a point recognised pursue leads of recruiting GP practices in two regions, very few of as the creative and energetic part of the researcher’s research those who initially seemed keen to help, ultimately engaged with journey [11]. This can be enhanced with adequate support from the research. Discussing such challenges openly will enable a wider the PhD researchers’ supervisors as well as the wider community discussion around methodological approaches to research such where the researcher hopes to engage. as RMRR and the possibility of undertaking sensitive research However, little attention has been given to self-funding, often differently in the future. For example, the Clinical Practice Research time international researchers, who regularly work additional Database (CPRD) presents an opportunity to explore patient’s data uncompensated hours to translate their growing research ideas into to enable change without the challenging process of recruiting GPs opportunities worthy of external support [12,13]; this means that and their practices. important contributory opportunities are missed or lie dormant Background due to the non-capitalisation of the expertise of the unsponsored Ethical approval was obtained from the NHS-Research Ethics PhD researcher. Committee (REC) of North of Scotland and London, who provided Narrative Approach and Reflection of Events opportunities for the student researcher to engage in individual Till date, there has been no publication on how the recruitment research projects within the NHS. The researcher began the process of recruiting GP practices in 2015 with personal visits and emails to researchers’ view of their data collection. Besides highlighting process in the NHS influences a PhD student or self-funded the recruitment process in the NHS and the impact of researching another email in 2016 after the meeting and approval of the study fulfil the requirement for the Ethics Board; these were followed with within the primary care system upon an often-isolated researcher, by the CCG contact. The research phase was completed in 2017, with this study presents a constructive view of the impact of the study. The underlying reasons for the limited participation as stated seven GPs in the interview phase and five practices for the RMRR recruitment process on the field researcher. After much effort Copyright@ Fidelia Bature | Biomed J Sci & Tech Res | BJSTR. MS.ID.003642. 16081 Volume 21- Issue 4 DOI: 10.26717/BJSTR.2019.21.003642

in order to have an opportunity to discuss the study with the GP challenges that suggested of the predictive model impossible; partners in the practice. The researcher came back full of hope but in terms of time and finances, there were several recruitment these challenges will be discussed in turn. It has been suggested that the research topic, invitation method, practice/GPs interest in for her and the GPs; she mentioned that this was standard practice at this meeting, the manager requested for financial recompense the research and managerial issues could present challenges in the before they could participate in any research. The researcher recruitment process [14]. explained to her that this was a PhD project without sponsorship but with ethical approval from the university and the NHS REC. However, the manager insisted that payment was a condition of as determinants for a successful recruitment in health care Earlier, Solberg et al. [15] identified seven research factors professionals including relationships with the local community; with the partners and communicate with the researcher within two reputation of the researcher with the host community; requirement participation and then affirmed that a meeting will be set again weeks. or resource demand; rewards in kind, cash and recognition; reciprocal as in negotiation; resolution in time or recruitment set Two weeks came and passed without contact and the time, and respect for participants duties and constraints as not to researcher proceeded to give her a call the following week without be taken for granted [10]. Consequently, the researcher and her success. The subsequent three visits yielded no outcome as on each supervisors came up with a topic that was interesting to physicians occasion; the researcher was told that the manager was so busy and patients alike, based on our own interests in AD, and the that she could not meet or speak with the researcher on the phone. belief that RMRR offered a unique way to screen practice notes b) Practices have no clear guidelines as to how and by retrospectively for common signs preceding the development of a whom a study will be assessed before they decide to engage. If clinically diagnosed disease (in many cases by decades rather than such guidelines existed, in our experience, they weren’t shared. weeks or years). Different methods of recruitment were employed The ethics approval is based on these practices indicating their including an interesting topic, adequate contact with gatekeepers, interest, however, how this is sought, is unclear. The only manager, personal visits, emails, telephone calls, and pair recruitment, etc. who responded to the CCG contact email, emailed the researcher It was then set out to invite the general practices in Milton Keynes (MK), the researcher’s hometown to participate in the and data collection. Unfortunately, when the manager learned that and fixed an appointment to meet in the practice for the interview study. Not only did the researcher visit the GPs practices as part she wasn’t going to be interviewed, she declined to participate on of the recruitment, but one of the supervisors accompanied the the grounds that she thought she would be interviewed not the GPs researcher to meet with the Clinical Commissioning Group (CCG) and subsequently insisted that her GPs were very busy and regret contact as a gatekeeper to increase the chances of GP recruitment. that their non-participation. The CCG contact responded positively and immediately drafted c) There was a lack of time and personnel to anonymise an email to all GPs and their practices in the MK area. However, the data before it was seen by the researcher. It was always “I am this only achieved a response from one GP practice manager, who sorry, this is our busiest time and we cannot participate”. When responded but later declined for reasons that will be explained the researcher requested to give some time and to come back, the below. The response rate for the recruitment was very low with response was “I am sorry, we would have to say no at this time.” only seven practices agreeing to enter a discussion following a Some GP practices were visited up to four times and the receptionist personal invitation by the researcher and pair recruitment initiated would suggest the lone student to come back again and again. In by the supervisor. There was variability with regards to who in the six independent practices, the practice managers emphasised that practices responded to our invitation (e.g. nurse, practice manager, their GPs will not participate based on the current crisis in primary GP). care including case overload and shortage of staff (Iliffe, 2018). The initial written invitation sent through email from the d) Requests for access by the researcher were sometimes researcher was followed up by phone calls and personal visits to dealt with as if personal favour was being asked. The researcher the practices to facilitate practice participation. Larger sample sizes was fortunate to meet with six managers personally and on three normally improve the ability of researchers to generalise about their occasions, the manager would greet a Caucasian female and state “Hi, you must be the researcher!” to which the black researcher findings [16] and we strived for this in our research. Throughout sampling in this study as follows: this process, we noted five matters that affected participation and stating that they were busy and asking the researcher to return at rose and responded in the affirmative. One of the managers kept incentives, which has become the norm for their participation in by shouting; “We don’t have any vacancy here”; the researcher then a) General practices operate within a culture of financial another time. On the fifth visit, the manager greeted the researcher studies. This is a known fact from several other programmes of insisted that she was not there to look for a vacancy but to present research [17-20]. The manager, that the researcher met in person, the document that was requested at the last discussion. showed interest and gave another date for a more detailed meeting

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Even though the manager apologised and said “I thought that you the black lady that had been here earlier to look for a job”; she patients’ outcomes [18,20]. Whilst we recognise the importance of responsible for the improvement in quality care and their benefit to further postponed the meeting, requested that the researcher visit good research that enriches health care in the UK and positively financial viability to practices, there need to be efforts to facilitate the system that they were using to anonymise their data. Luckily, impacts local communities including our understanding of disease other GP practices that have signed up for the study and find out one of the practices obliged this information, which again was initiation, and progression, for those that care for others. presented to the manager, who at this time, bluntly stated that the Funding by outside organisations such as the National Institute practice could not participate. This is an indication that individual for Health Research (NIHR) Clinical Research Network (CRN) are highly competitive, provide focussed research support and are time- gatekeeperse) There influenced are physicians the positioning who take oftime the to researcher. support studies that consuming to apply for. Moreover, funding from these organizations are close to their interests without requesting a reward. Although is not always available for international self-sponsored students. such initiatives are commendable and do enable studies to be The lone researcher is often underfunded, in contrast to large well- conducted, the very small number physicians who might decide funded groups, and spends their own time, and money, gathering research data. Guidance setting out the pathways in which GPs can numbers to provide our studies with the generalisability it could to support a study because of their interests, were insufficient in have generated. Also, regardless of how important such initiatives support research, that benefit practices that engage with some may be to individual studies, there is a lack of understanding of will not only facilitate the non-sponsored and lone researcher but studies, is needed. Clear guidelines/financial support for research how a decision is made to support or not to support a study by a provide a greater contribution to STEM and healthcare knowledge practice. One of the GPs was enthusiastic about participating but for the evidence-based practice advocated by the U.K. government. would only do so when his practice manager consented to his While Section 3.7 of the Health Research Authority (HRA) participation; however, the practice manager refused to consent Ethics Guidance to Payment and Incentives in Research states that on the grounds that they had too many patients with too few “Where the risk and burdens of the research are considered by a GPs. This supports Loskutova et al. [14], who reiterated that most recruitment challenges represent managerial challenges, who are be acceptable for competent adults to participate in the research sometimes not experienced enough to decide on the importance of REC to be justified by the potential benefits then it will normally study without being paid ”, Section 3.8 indicates that “Where it is a study. considered ethically acceptable for individuals to take part in a Discussion study for no payment it would also be acceptable to pay individuals for participation in that study proportionate to the level of burdens impacted negatively on a research project that had the potential to In this reflective piece, we have mentioned five challenges that to the level of involvement like data collection should clearly be contribute positively to patients’ outcome. We elaborate as follows: involved and/or (justified) risk”. However, payment in proportion Government funding and subsidisation provide general practices what they are involved in. with operational sustainability, as their role in the community is defined and generalized for researchers to have an anticipation of Gatekeeping plays an important role in facilitating research access, as it determines whether research poses a threat to the recognised as paramount. The culture of financial support has been for participating in public health programmes such as those of extended to provide individual practices with financial rewards is understood that vigilance by gatekeepers is important especially participants or the public at large or offers benefits to society. It rewarded for their participation in local and national committees when this has to do with patients’ data, which requires careful integrated care and research [19,20]. GPs are normally financially consideration of the ethical implications and the approvals given in public health programmes and research, programmes of [18]. Within this culture of financial compensation for participating [21]. However, it is difficult, as in our case, to determine the motives rewards to general practices may never materialize or may not they are in fact just following instructions from the GPs, who are research which do not have access to funds to provide financial of the gatekeepers and their degree of influence on GPs; or whether produce the maximum impact needed especially with the emphasis indeed, their line managers. Furthermore, RMRR gatekeepers on evidence-based practice. should consider and emphasise the issues of access and possibly Indeed, the request by practices for compensation for the limit their roles in preventing research from progressing, especially anonymization of patient notes prior to release to a researcher when ethics has been approved by the issuing authority. Permission is not an unreasonable one, especially if the monies provided by should be given solely in consideration of the resource implications government funding are entirely accounted for. However, most and the expected time contribution required by the research. researchers without sponsors do not have the capacity to provide Ironically, research requires continuous negotiation with gatekeepers, which is a demonstration of transparency and respect are controversies as to the extent to which these incentives are for institutional autonomy [21,22], but how long these negotiations financial compensation/incentives for their participation and there

Copyright@ Fidelia Bature | Biomed J Sci & Tech Res | BJSTR. MS.ID.003642. 16083 Volume 21- Issue 4 DOI: 10.26717/BJSTR.2019.21.003642 should take and what is required to make it through these practice management that have engaged in research because of the barriers is not clear. Should research be delayed just to wait for the contribution that the research will make on healthcare development gatekeeper’s permission? Careful consideration and respect for in general, often based on their own areas of interest. the time of the researcher are also needed. Indeed although some This is a call to educate gatekeepers on the great contribution GPs were incredibly helpful and supportive of the research, the that research can bring to our understanding of disease but most unnecessary time and cost associated with referring the researcher importantly, how they, or indeed GPs communicate with researchers. to a gatekeeper whose job it was to say ‘maybe’, ‘come back’ and Once a proposal is peer-reviewed and approved, general guidance eventually ‘no’, could have been circumvented by a more direct to encourage or indeed force government-funded GP practices to engage with some hours per month or year with research could time and frustration. Had gatekeepers/GPs given a clear ‘no’ at the and honest answer at the first contact, saving everyone involved facilitate research-led improvements in primary care. The provision of a letter from the GP to the practice manager agreeing to engage new leads in a wider area, instead of chasing potential leads in a first meeting, the researcher would have had more time to pursue and a quick tick box form for the practice manager to return to the diminishing time-frame. research explaining if the practice won’t engage why not (Figure 1) This was particularly frustrating when the researcher was asked may have circumvented a number of face-to-face meetings between to return to the practice over and over again, in some instances up the researcher and practice that ultimately led to no progress in the to six times. This said and done, it could indicate that there was a research. Even though we are advocating for researchers to make willingness, however, without a means in time or resources. Power use of the databases created for patients and accept that these dynamics also play a part in how research is undertaken within databases can help avoid the challenges we faced, electronic health the health and social care. This also had a part in our research records are not suitable for many research questions, especially as indicated in the narratives. The reason has been attributed to without the explicit knowledge of the complexities and limitations weak and opaque management; inadequate guidelines for research of these types of data [6]. These complexities arise out of the and development facilitated by primary care providers, failure to variation in health care processes across countries, as well as issues recognize the potential of engaging in research and the support that of safety and security around patient data [5,24]. Furthermore, to research contributions need, as well as the lack of clear guidelines

access the data requires finances, which might not be available to and definition of roles [23]. Ironically, we have witnessed some the lone or self-financed researcher.

Figure 1: Process of recruitment (A) process followed (with numbers involved (n=) or date completed in parentheses); (B) following experience and reflection – process recommended to future investigators.

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Patients’ medical records present an opportunity for researchers 9. Draper H, Wilson S, Flanagan S, Ives J (2009) Offering payments, reimbursement and incentives to patients and family doctors to encourage participation in research. Family practice 26(3): 231-238. in signs and symptoms of diseases, which can help in the early to deliver more efficient studies in our case by identifying patterns 10. Dubois B, Padovani A, Scheltens P, Rossi A, Dell’Agnello G (2016) Timely diagnosis of diseases and deliver timely healthcare intervention. However, with General Practices in crisis [25], the workload has challenges. Journal of Alzheimer’s disease 49(3): 617-631. diagnosis for Alzheimer’s disease: a literature review on benefits and become more complex and intensive without the funds to support 11. Ewing G, Rogers M, Barclay S, McCabe J, Martin A et al. (2004) Recruiting the workforce and the complex infrastructure required [26]. As patients into a primary care-based study of palliative care: why is it so the pressure has grown, patient experience has also deteriorated [27-36], with a knock-on effect that the recruitment of practices for 12. difficult?(2019) Health Palliative Research Medicine Authority 18(5): 452-459. Ethics Guidance. Payment and Incentives in Research. research that would contribute in improving patients’experience 13. H yland S, Hollund JG, Olsen OE (2015) Gaining access to a research has become almost impossible. We advocate for more funding ø site and participants in medical and nursing research: A synthesis of and enlightenment in terms of what research means to healthcare accounts. Medical Education 49(2): 224-232. development, on how patient notes can be made accessible for 14. Iliffe S (2018) Healthcare on the brink? Assessing the crisis in General those with appropriate ethical approvals in place. Practice. Renewal 26(2): 76-88.

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